Code of Practice for the Pharmaceutical Industry

Transcription

1 Edition 8.1 Code of Practice for the Pharmaceutical Industry

2 IPHA Code of Practice for the Pharmaceutical Industry Edition 8.1 Jan 2015 Irish Pharmaceutical Healthcare Association Ltd. Wilton Park House, Wilton Place, Dublin 2 Tel: +353 (1) Fax:+353 (1) info@ipha.ie Website:

3 Code of Practice for the Pharmaceutical Industry IPHA The Irish Pharmaceutical Healthcare Association (IPHA) represents the international research-based pharmaceutical industry in Ireland. Its member companies include both manufacturers of prescription medicines and non-prescription or consumer healthcare medicines. 1

4 Introduction The Code has been prepared by the Irish Pharmaceutical Healthcare Association (IPHA) with a view to securing the universal acceptance and adoption of high standards of conduct in the interactions with healthcare professionals, healthcare organisations and patient associations, and the marketing of medicinal products to healthcare professionals, whether intended for use under medical supervision or otherwise. The advertising of medicinal products for human use in European Union Member States is governed by Council Directive 2001/83/EC of 6 November 2001, as amended. This Code of Practice fits into the general framework established by Article 97 Paragraph 5 of Directive 2001/83/EC as amended, which recognises the role of the voluntary control of advertising of medicinal products by self-regulatory bodies and recourse to such bodies. The Code emphasises the importance of providing healthcare professionals with accurate, fair and objective information about medicinal products so that rational decisions can be made as to their use. Moreover, the Code accepts the principle that such information must be presented in a form and by ways and means which conform not only to legal requirements but also to professional standards of ethics and good taste. Acceptance and observance of the provisions of the Code and its annexes are a condition of membership of the IPHA. Companies observing the Code also acknowledge that its provisions are to be applied in spirit, as well as in the letter. 2

5 Code of Practice for the Pharmaceutical Industry The provisions of the Code fully reflect the standards of the June 2013 edition of the EFPIA Code on the Promotion of Prescription-only Medicines to, and Interactions with, Healthcare Professionals, June 2011 EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations and EFPIA Code on Disclosure of Transfers of Value from companies to Healthcare Professionals and Healthcare Organisations which are published by the European Federation of Pharmaceutical Industries and Associations (EFPIA). IPHA is a member of EFPIA. Compliance with the European Code is a requirement of all member associations of EFPIA. This IPHA Code of Practice incorporates the provisions of the Medicinal Products (Control of Advertising) Regulations 2007 (S.I. 541 of 2007) for the purposes of providing practical guidance in implementing the Regulations. The Minister for Health, as provided for under Regulation 26 of the Medicinal Products (Control of Advertising) Regulations 2007 [the Regulations ], endorses the parts of the IPHA Code of Practice for the Pharmaceutical Industry, that are directly derived (verbatim) from the aforementioned Regulations. This Code has been provided to help in implementing the requirements of the Regulations. It is designed to be used in conjunction with the Regulations and is, by no means, a substitute for the Regulations. 3

6 Contents 1. Scope & Definition of Terms 6 2. Methods of Promotion 8 3. Marketing Authorisation 8 4. Nature & Availability of Information 9 5. Claims & Comparisons Disparaging References Textual & Audio-Visual Promotional Material References to the Health Products Regulatory 14 Authority & Related Organisations 9. References to the Primary Care 14 Reimbursement Service 10. Distribution of Promotional Material Reprints, Abstracts & Quotations Company Employees 17 (Direct and Contracted) 13. Samples Gifts 21 4

7 Code of Practice for the Pharmaceutical Industry 15. Grants & Other Forms of Support Hospitality, Sponsorship & Meetings Use of Consultants Market Research, Post Marketing Surveillance & 29 Related Activities 19. Non-Interventional Studies Relations with the General Public & Lay 32 Communication Media 21. Company Procedures for Code Compliance 33 ANNEXES Annex I: Administration of the Code & 35 Complaints Procedure Annex II: Guideline on Nursing Services Provided by 55 companies Annex III: Guideline for companies on Working 58 with Patient Associations Annex IV: Guideline on Digital Communication in 68 the Pharmaceutical Sector Annex V: IPHA Code on Disclosure of Transfers of 76 Value from companies to Healthcare Professionals and Healthcare Organisations 5

8 Provisions of the Code 1. Scope & Definition of Terms 1.1 The Code covers interactions with healthcare professionals, healthcare organisations and patient associations, and the promotion to healthcare professionals of prescription-only medicinal products. 1.2 The term promotion means those marketing and informational activities coming under the control or authority of the company, the purpose of which is to induce the prescribing, supply, sale or consumption of the company s products. Promotion includes, for example, the activities of medical representatives; various aspects of sales promotion such as journal and direct mail advertising, the use of mail (including post, telephone, , and other electronic means of communication), the use of the internet, the use of audio-visual materials such as films, video recordings, data storage services and the like, informational systems and exhibitions; press releases and the provision of samples, gifts or hospitality. 1.3 The term healthcare professional means a person of any of the following classes: (i) (ii) (iii) (iv) Registered medical practitioners Registered dentists Registered pharmacists Registered nurses 1.4 The term medicinal product means: 6 (i) (ii) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings. Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions

9 Code of Practice for the Pharmaceutical Industry by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. 1.5 The term marketing (or product) authorisation refers to a medicinal product licence granted or renewed by the Health Products Regulatory Authority or the European Commission. 1.6 The Code is not intended to inhibit the exchange of medical and scientific information during the development of a product. 1.7 The Code does not cover: - the labelling of medicinal products and the accompanying package leaflets, which are subject to the provisions of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. 540 of 2007) as amended; - correspondence, possibly accompanied by material of a nonpromotional nature, needed to answer a specific question about a particular medicinal product. Non-promotional, general information about companies (such as information directed to investors or to current/prospective employees), including financial data, descriptions of research and development programmes, and discussion of regulatory developments affecting the company and its products. - factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims; - books, journals, periodicals and other publications that are imported into the State and which contain advertising which is not intended for, or directed at, persons resident in the State; - information relating to human health or diseases provided there is no reference, even indirect, to medicinal products. 7

10 2. Methods of Promotion 2.1 Methods of promotion must never be such as to bring discredit upon or reduce confidence in the pharmaceutical industry. 3. Marketing Authorisation 3.1 A medicinal product must not be promoted prior to receipt of the marketing authorisation authorising its sale or supply. 3.2 The promotion of a medicinal product must be consistent with the terms of the marketing authorisation. 3.3 At international congresses or symposia held in Ireland, promotional material which appears on exhibition stands or is distributed to participants may refer to a medicinal product or indication for a medicinal product which is not the subject of an authorisation in Ireland (but which is so authorised in at least one Member State of the European Economic Area [EEA]) provided that the following conditions are observed: (i) (ii) (iii) The meeting must be a truly international, scientific event with a significant proportion of the speakers and delegates from other countries; To ensure that the promotional material does not promote the prescription, supply, sale or consumption of the medicinal product in Ireland, a clearly visible and legible statement must be included to the effect that the medicinal product is not authorised in Ireland or that it is authorised for different indications in this country; Promotional material which refers to the prescribing information (indications, warnings etc.) authorised in other countries must include an explanatory statement indicating that licensing conditions differ internationally. 8 Promotional material for medicinal products which are not authorised in any EEA country at the time of the congress or

11 Code of Practice for the Pharmaceutical Industry symposium, may not be displayed or distributed to participants. Scientific papers on such products may, however, be provided in accordance with Clause 1.6 of the Code. 4. Nature and Availability of Information 4.1 Upon reasonable request, a company must promptly provide healthcare professionals with accurate and relevant information about the medicinal products which it markets. 4.2 Information about medicinal products must be up-to-date, verifiable and accurately reflect current knowledge or responsible opinion. 4.3 Information about medicinal products must be accurate, balanced, fair, objective and must not mislead either directly or by implication. 4.4 Information must be capable of substantiation. Such substantiation need not be provided however in relation to the validity of indications approved in the marketing authorisation. 4.5 Substantiation that is requested pursuant to Clause 4.4 must be provided without delay at the request of members of the medical and pharmacy professions including the members of those professions employed in the pharmaceutical industry. 4.6 When promotional material refers to published studies, clear references must be given. 4.7 In accordance with an agreement reached between the IPHA and the Department of Health, the summaries of product characteristics (SmPCs) relating to individual medicinal products are included in which is made available free of charge to healthcare professionals in Ireland. The contents of the SmPCs in that Compendium are determined by the relevant marketing authorisations. 9

12 4.8 The provision of informational or educational materials is permitted provided the materials are: (i) inexpensive; (ii) directly relevant to the practice of medicine or pharmacy; and (iii) directly beneficial to the care of patients. Such items may be company branded. Materials provided for informational or educational reasons may include: scientific articles and items used to provide information about medicinal products (such as detail aids); patient education materials given to healthcare professionals for use with their patients, etc. Companies may provide pens or paper pads exclusively during company-organised meetings, as long as they are not-product branded and inexpensive. Companies shall not distribute pens or paper pads at exhibition stands. Pens or paper pads included in conference bags shall not be branded (neither product nor company branded). 4.9 HCPs may be provided with items which are to be passed on to patients which may bear the name of a medicine and/or information about medicines only if such detail is relevant to the appropriate use of the medicine by patients who have been prescribed that medicine. Additionally, although items which are to be passed on to patients may not be issued at HCP exhibition stands, they may be exhibited and demonstrated on HCP stands and requests for them accepted for later delivery. Patient support items may be provided to HCPs by medical representatives during the course of a promotional call and medical representatives may deliver such items when requested by a HCP. In limited circumstances patient support items may be made available for the use of HCPs even though they are not to be passed on to patients for them to keep. This is where their purpose is to allow patients to gain experience in using their medicines whilst under the supervision of a HCP. Examples include inhalation devices (with no active ingredient) and devices intended to assist patients to learn how to self-inject Items of medical utility aimed directly at the education of healthcare professionals and patient care may be provided if they

13 Code of Practice for the Pharmaceutical Industry are inexpensive and do not offset the cost of routine business practice of the recipient. Such items may be company branded. In addition, it might also be acceptable to use the product branding, when the item is used with that medicine, within the limits permitted by laws and regulations. 5. Claims & Comparisons 5.1 Claims for the usefulness of a medicinal product must be based on an up-to-date evaluation of all the evidence and must reflect this evidence accurately and clearly. Such claims must have prior medical review and approval. 5.2 Exaggerated claims must not be made and all-embracing claims and superlatives avoided. Claims must not imply that a medicinal product, or an active ingredient, has some special merit, quality or property unless this can be substantiated. 5.3 The word safe must not be used without qualification and it must not be stated categorically that a medicine has no side-effects, toxic hazards or risk of addiction (see also Clause 7.2). 5.4 The word new must not be used to describe any medicinal product which has been generally available, or therapeutic indication which has been generally promoted, in Ireland for more than 12 months. 5.5 Comparisons of medicinal products must be factual, fair and capable of substantiation. In presenting a comparison, care must be taken to ensure that it does not mislead by distortion, by undue emphasis, omission or in any other way. 5.6 Brand names of products of other companies must not be used in comparison unless the prior consent of the companies concerned has been obtained. 11

14 6. Disparaging References 6.1 Other companies, their products, services or promotions must not be disparaged either directly or by implication. 6.2 The clinical and/or scientific opinions of members of healthcare professionals must not be disparaged either directly or by implication. 7. Textual and Audio-Visual Promotional Material 7.1 All promotional material issued by a marketing authorisation holder or with his authority, must be consistent with the requirements of this Code. 7.2 Where the purpose of promotional material is to provide persons qualified to prescribe or supply with sufficient information upon which to reach a decision for prescribing or for use, then the following minimum information, which must be compatible with the SmPC, must be given clearly and legibly and must be an integral part of the advertisement: 12 (i) (ii) (iii) (iv) The relevant marketing authorisation number and the name and address of the holder of the authorisation or the business name and address of the part of the business responsible for placing the medicinal product on the market; The name of the product, and a list of the active ingredients, using the common name, placed immediately adjacent to the most prominent display of the name of the product; One or more of the indications for the use of the product compatible with the terms of the marketing authorisation; Recommended dosage, method of use and, where not obvious, method of administration;

15 Code of Practice for the Pharmaceutical Industry (v) (vi) (vii) The classification for the sale or supply of the product; Adverse reactions, warnings and precautions for use and relevant contraindications of the product; A statement that additional information is available on request; (viii) The date on which the above particulars were generated or last updated. 7.3 Where the purpose of the promotional material is to remind persons qualified to prescribe or supply of the availability and of the indication(s) of a medicinal product (i.e. a reminder advertisement ), the following information, which must be compatible with the SmPC, must be included: (i) (ii) (iii) (iv) The name of the medicinal product, or the international non-proprietary name, where such exists, or the trademark; A statement which clearly indicates that further information is available on request or in the SmPC; The name and address of the holder of the marketing authorisation or the business name and address of the part of the business responsible for placing medicinal product on the market; The classification for sale or supply of the product. All promotional material not falling within the category of reminder advertisements must comply with Clause Promotional material such as mailings and journal advertisements must not be designed to disguise their real nature. Where a company pays for or otherwise secures or arranges the publication of promotional material in journals, such promotional material must not resemble editorial matter. 13

16 7.5 All promotional material appearing in journals, the publication of which is paid for, secured or arranged by a company and referring by brand name to any product of that company, must comply with Clause 7.2 or 7.3 of this Code as appropriate, irrespective of the editorial control of the material published. 7.6 Promotional material must conform, both in text and illustration, to canons of good taste and must be expressed so as to recognise the professional standing of the recipients and not be likely to cause offence. 7.7 The names or photographs of healthcare professionals must not be used in promotional material without their permission nor in any way that is contrary to the ethical code of the appropriate profession. 7.8 Promotional material must not imitate the devices, copy, slogans or general layout adopted by other companies in a way that is likely to mislead or confuse. 7.9 Where appropriate (for example, in technical and other informative material), the date of printing or of the last review must be stated Extremes of format, size or cost of promotional material must be avoided Postcards, other exposed mailings, envelopes or wrappers must not carry matter which might be regarded as advertising to the lay public or which could be considered unsuitable for public view Audio-visual material must be accompanied by all appropriate printed material so that all relevant requirements of the Code are complied with. 14

17 Code of Practice for the Pharmaceutical Industry 8. References to the Health Products Regulatory Authority & Related Organisations 8.1 Unless specific requirements with regard to distribution or use have been imposed, companies must not include in any announcement or promotional material, a statement that the marketing of the product has been approved or recommended by the Health Products Regulatory Authority or related organisations such as the European Medicines Agency (EMA), the European Commission or the Committee for Medicinal Products for Human Use (CHMP). 9. References to the Primary Care Reimbursement Service 9.1 References to the Primary Care Reimbursement Service (PCRS) (or the GMS as it was previously known) in promotional material must be confined to including the relevant code number, the print size and typeface of which must be the same as that of the marketing authorisation number. 9.2 Where reference is made to the prescribing of a product under the PCRS, the phrase freely prescribable or similar phrases suggesting a lack of restriction or restraint must not be used. 9.3 Where a product has been added or restored to the PCRS list, announcements, advertisements and other communications to this effect may include in the body of prescribing information, a statement that the product is PCRS reimbursable (or similar) provided that the print size of such statements is no larger than the rest of the text. Such a statement may be carried for no longer than twelve months from the date of the adding or restoring of the product to the PCRS list. 9.4 Reproductions of official documents, such as prescription forms, must not be used for promotional purposes unless the agreement of the appropriate State Organisation has been received. 15

18 10. Distribution of Promotional Material 10.1 Promotional material must only be sent or distributed to those categories of persons whose need for, or interest in, the particular information can be reasonably assumed. Promotional material must be tailored to the audience to whom it is directed. For example, promotional material devised for general practitioners might not be appropriate for hospital doctors Any information designed to encourage the use of medicinal products in clinics, industrial concerns, clubs or schools must be addressed to the appropriate healthcare professional Restraint must be exercised on the frequency of distribution and on the volume of promotional material distributed. The style of mailings is relevant to their acceptability to healthcare professionals and criticism of their frequency is most likely to arise where their informational content is limited or where they appear to be elaborate and expensive Mailing lists must be kept up-to-date. Requests from healthcare professionals to be removed from promotional mailing lists must be complied with promptly and no name should be restored except at the healthcare professional s request or with his/her permission The use of faxes, s, automated calling systems, text messages and other electronic data communications for promotion is prohibited except with the prior permission, or upon the request, of the recipient. 11. Reprints, Abstracts & Quotations (Such use is, of course, subject to the Law of Copyright) All reprints of articles supplied to individual healthcare professionals in the course of promotion must comply with the provisions of Clause 7.2 or 7.3 as appropriate.

19 Code of Practice for the Pharmaceutical Industry 11.2 It is permissible to include in promotional material, reasonably brief abstracts of, or quotations from, articles, or accurately reproduced tables or other illustrative matter taken from the scientific literature and to include in such material references to authors names in a bibliography of published works. In no case however, should authors names be used in a prominent manner in promotional material Quotations from medical literature, or from personal communications received from healthcare professionals, must accurately reflect the meaning of the author and the significance of the study. 12. Company Employees (Direct and Contracted) 12.1 The term medical representatives includes medical sales representatives, including personnel retained by way of contract with third parties, and any other company representatives who call on healthcare professionals, pharmacies, hospitals or other healthcare facilities in connection with the promotion of medicinal products Medical representatives must be provided with thorough training by the company which employs them and possess sufficient scientific knowledge to present information on the company s products in an accurate, complete and responsible manner. The contribution of the Medical Representatives Institute of Ireland in this respect (for example by the inclusion of the IPHA Code of Practice in its examination syllabus) is acknowledged During each visit medical representatives must give the person visited or have available for them, the most up-to-date version of the SmPC for each medicinal product they promote. Where the SmPCs are published in a compendium such as that has been delivered to the class of healthcare professional visited within the previous twelve months, and this fact is drawn to the attention of the persons visited, this requirement is deemed to be satisfied. 17

20 12.4 All company employees must transmit to the Scientific Services established in their companies any information on adverse reactions reported to them by the persons they visit Medical representatives must at all times maintain a high standard of ethical conduct in the discharge of their duties. They must comply with all relevant requirements of the Code Medical representatives must not employ any inducement or subterfuge to gain an interview. They must not pay, under any guise, for access to a healthcare professional. This clause does not preclude the occasional provision of light refreshments/modest meals at a meeting organised by a medical representative. Such hospitality may only be provided to healthcare professionals and occur in a manner and venue conducive to information exchange and/or scientific education. Payments to healthcare professionals to cover the cost of such hospitality are not allowed Medical representatives must ensure that the frequency, timing and duration of calls on healthcare professionals, or on hospitals, together with the manner in which they are made, are acceptable to the healthcare professionals and hospitals as appropriate and are not such as to cause inconvenience. The wishes of an individual healthcare professional, or the arrangements in force at any particular establishment, must be observed by representatives. Medical representatives must always endeavour to treat healthcare professionals time with respect and if for any reason an appointment cannot be kept by the representative, the longest possible notice must be given Medical representatives must take adequate precautions to ensure the security of medicinal products in their possession Medical representatives must not use the telephone or similar electronic means to promote medicinal products to the medical profession unless prior arrangement has been made with individual healthcare professionals.

21 Code of Practice for the Pharmaceutical Industry Companies are responsible for the activities of all their employees and must ensure that employees who are concerned in any way with the drafting or approval of promotional material (including employees of third parties contracted on behalf of the company) are fully conversant and compliant with the requirements of the Code. Other third parties working for or on behalf of companies, (including advertising company executives, business consultants and market research companies), and those that do not act on behalf of companies (such as joint ventures and licensees) commissioned to engage in activities covered by the Code should also have a good working knowledge of the Code The provision of nursing services by a company must be undertaken in accordance with the guideline on the provision of nursing services by companies published in Annex II Companies must ensure that all regulatory obligations are met. In particular their pharmacovigilance departments must be notified of and/or involved in, as appropriate, activities such as market research, Patient Support Programmes etc. 13. Samples 13.1 Free samples of medicinal products shall not be supplied to any person who is not qualified to prescribe such product. The supply of a sample means the supply of a medicinal product made otherwise than in connection with a clinical trial notified or authorised under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004 (S.I. 190 of 2004) as amended Where samples of products are distributed by a medical representative, the sample must be handed directly to a person qualified to prescribe such product or to a person authorised to receive the sample on their behalf The following conditions shall be observed in the provision of samples to a person qualified to prescribe such product: 19

22 (i) (ii) (iii) (iv) (v) (vi) (vii) Such samples are provided on an exceptional basis only (see (ii) to (vii) below) and for the purpose of acquiring experience in dealing with such a product; Such samples in respect of a medicinal product shall not exceed four in number per year and sampling shall not extend beyond the two years after he/she first requested samples of each particular new medicine. In this context, a new medicine is a product for which a new marketing authorisation has been granted, either following an initial marketing authorisation application or following an extension application for new strengths/dosage forms that include a new indication. Extensions of the marketing authorisation to additional strengths/dosage forms for existing indications or pack sizes (number of units in the pack) cannot be considered as new medicines. Any supply of such samples must be in response to a signed and dated request from the recipient; An adequate system of control and accountability must be maintained in respect of the supply of such samples. This system shall also clearly establish, for each person supplied, the number of samples provided in application of the provision in Clause 13.3(ii); Each sample shall be no larger than the smallest presentation on the market; Each sample shall be marked free medical sample not for sale or bear another legend of analogous meaning; Each sample shall be accompanied by a copy of the most up-to-date version of the SmPC relating to that product in accordance with the requirements set out in Clause A person shall not supply a sample of a medicinal product which is a controlled drug under Section 2 of the Misuse of Drugs Act, 1977 and 1984 or which is an anti-depressant, hypnotic, sedative or tranquilliser.

23 Code of Practice for the Pharmaceutical Industry 13.5 Samples sent by post must be packed so as to be reasonably secure against the package being opened by children Distribution of samples in hospitals must also comply with individual hospital regulations, if any. 14. Gifts 14.1 No gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply by a company in relation to the promotion/ marketing of prescription medicines. This does not preclude any regulations for the time being in force relating to prices, margins and discounts. 15. Grants & Other Forms of Support 15.1 Clause 14 shall not preclude a company from providing support in the form of educational, research or employment grants, donation or sponsorship of equipment for the betterment of patients, provided that the following conditions are complied with: (i) (ii) (iii) The company must be in receipt of a written request from a healthcare professional or institution (for example, a practice, medical centre, clinic or hospital) for the specific type of support provided, as the case may be. Sufficient information must be obtained to establish that there is a genuine need for such support; Educational, equipment, employment or research grants must be paid directly to an institution rather than to an individual healthcare professional; Any such support provided by a company must be relevant to the practice of medicine or pharmacy and must be given to an institution rather than to an 21

24 individual healthcare professional and intended solely for use in the institution; (iv) (v) Any such support must not be linked in any way with product promotion. No commitment must be sought or given in relation to the prescribing, supply or use of the company s products; Any such support must be reasonable, modest and in proportion to the scale and scope of the recipient institution and must be likely to appear so to independent third parties. Additionally, from 2016 onwards companies will be required to make public details of all Transfers of Value that occur from January 2015 (see Appendix V of this Code for full details). 16. Hospitality, Sponsorship & Meetings (see also Annex V on HCP Transparency requirements) 16.1 The pharmaceutical industry has a special obligation to ensure that healthcare professionals are kept constantly in touch with continuing developments in the pharmaceutical field. With this in mind, the practice has arisen of meetings and events being organised between the industry and the professions for the further exchange of ideas and information. In addition, the custom has grown of the industry supporting independent meetings of healthcare professionals intended to update and expand the continuing education of the professions themselves. 22 Many of these meetings could not take place without the support and assistance of the pharmaceutical industry. Companies may legitimately provide assistance that is directly related to the bona fide continuing education of the healthcare professionals and which genuinely facilitates attendance of the healthcare professional for the duration of the educational aspect of the event. Such support and assistance must however, always be such

25 Code of Practice for the Pharmaceutical Industry as to leave healthcare professionals independence of judgement manifestly unimpaired Where appropriate and depending on the time, location and length of the meeting, support to healthcare professionals may cover actual travel expenses, meals, refreshments, accommodation and registration fees Companies shall not provide or offer any meals to healthcare professionals, unless, in each case (i.e. per meal and per recipient), the value of such meals (food and beverages) does not exceed the current monetary threshold set by IPHA of 80 (including VAT and excluding any gratuity). It should be remembered that this threshold is in addition to the existing restrictions on hospitality (reasonable, secondary to the main purpose and in compliance with all other aspects of the Code) and only applies to events in Ireland. Where the hospitality occurs in another member state bound by the EFPIA Code the hospitality threshold set in that member state will apply It should be the programme that attracts delegates and not the associated venue or hospitality. Companies must not organise meetings to coincide with sporting, entertainment or other leisure events or activities. Venues that are renowned for their entertainment or leisure facilities or are extravagant must not be used In addition to the requirements of clause 16.3 any hospitality offered to healthcare professionals must: (i) (ii) (iii) Be reasonable in level and be likely to appear to independent third parties, to be reasonable; Be secondary and strictly limited to the main purpose of the event at which it is offered; Not exceed the level that recipients would normally be prepared to pay for themselves; 23

26 (iv) (v) Not be extended to spouses or other accompanying persons, unless they are healthcare professionals who qualify as participants in their own right. Travel expenses may not be paid for spouses or other accompanying persons, unless they are healthcare professionals who qualify as participants in their own right; Not include sponsoring, securing, organising directly or indirectly any entertainment, sporting or leisure events Funding of healthcare professionals to compensate them for the time spent in attending the event is not permitted All promotional, scientific or professional meetings, congresses, conferences, symposia, and other similar events (including, for example, advisory board meetings, visits to research or manufacturing facilities, and planning, training or investigator meetings for clinical trials and non-interventional studies) (each, an event ) organised or sponsored by or on behalf of a company must be held at an appropriate venue that is conducive to the main purpose of the event A company may not organise or sponsor an event or a participant at an event that takes place outside Ireland (an international event ) unless there is a valid reason to do so. All the previous relevant provisions must be applied together with the following additional principles: 24 (i) (ii) (iii) Most of the invitees are from outside Ireland and, given the countries of origin of most of the invitees, it makes greater logistical sense to hold the event in another country or; Given the location of the relevant resource or expertise that is the object or subject matter of the event, it makes greater logistical sense to hold the event in another country; As with meetings held in Ireland, consideration must be given to the educational programme, overall cost, facilities offered by the venue, nature of the audience

27 Code of Practice for the Pharmaceutical Industry and the hospitality to be provided, which must be secondary to the meeting and not out of proportion to the occasion; (iv) Any hospitality offered to healthcare professionals at international meetings must: (a) Be reasonable in level and be likely to appear to independent third parties, to be reasonable; (b) Be secondary and strictly limited to the main purpose of the event at which it is offered; (c) Not exceed the level that recipients would normally be prepared to pay for themselves; (d) Not be extended to spouses or other accompanying persons, unless they are healthcare professionals who qualify as participants in their own right; (e) Not include sponsoring, securing, organising directly or indirectly any entertainment, sporting or leisure events or activities; (f) Actual travel expenses of healthcare professionals may be covered, but the payment of travel expenses for spouses and accompanying persons is not permitted; (g) It should be the programme that attracts delegates and not the associated venue or hospitality; (h) To avoid any confusion as to the primary purpose of the event, international events should not coincide with a major event of a sporting or social nature in a locality The following additional requirements shall apply in relation to the sponsorship of meetings convened by the healthcare professions: 25

28 (i) Smaller meetings The sponsorship of local clinical meetings, initiated by an organising body of the healthcare professions, is frequently sought from companies. In such instances, companies must respond only to formal written requests for support from the organising committee. Any request for support should indicate the exact anticipated items of expenditure for which the support is sought. Support must not extend beyond: - cost of room hire - cost of equipment hire - actual travel expenses of speaker(s) - honorarium to speaker(s) if appropriate - modest meals and/or light refreshments Promotional input from companies at an appropriate stage of the meeting must be with the agreement of the Chairman or through a printed acknowledgement on the programme (if any). In any series of such meetings, as for example during the winter season, no one company should undertake the sponsorship of such a series of meetings to the exclusion of other available and willing sponsors. No payment must be made by a company in order to be included on a shortlist of possible sponsors. (ii) Larger meetings For larger meetings initiated by the healthcare professions, such as annual association meetings, support usually involves the rental of a stand or space for the purposes of exhibiting the company s product range. This form of exhibition by companies is acceptable. As far as possible, for reasons of security, medicinal products must not be brought to such meetings. In no circumstances should medicinal products be handed over to visitors to the stand or exhibition. 26

29 Code of Practice for the Pharmaceutical Industry Other support for such meetings must not extend beyond a contribution to the general expenses of the meeting. An acknowledgement of this support, by way of a list of sponsors on the programme (if any) and/or by way of a similar list displayed on a notice board, is acceptable. Sponsorship of major annual or bi-annual meetings of any discipline within the healthcare professions should not be undertaken by any one company to the exclusion of other available and willing sponsors. No payment must be made by a company in order to be included on a shortlist of possible sponsors Corporate Hospitality Aside from meetings and events as referred to in the preceding paragraphs, it is recognised that, on occasion, companies may provide what may be considered as corporate hospitality (e.g. opening a new office). Corporate hospitality involving sporting, entertainment or social events or activities must not be extended to healthcare professionals. However, on an occasional basis, corporate hospitality involving events organised by not for profit organisations and/or a bona fide registered charity may be extended to healthcare professionals provided that the clear and transparent objective of the event or activity itself, is to raise funds for charitable or benevolent purposes. Such events must not involve or be in any way associated with major sporting or social events. The following principles shall apply to corporate hospitality: (i) (ii) There must be no element of product promotion at the event, either direct or implied; Companies should appreciate the need for moderation. Corporate hospitality must never be such that, on a reasonable view, it might give rise to the inference that 27

30 the scale and costs of such hospitality could adversely affect the cost of medicines to the patient or taxpayer; (iii) Corporate hospitality should be reasonable in level and likely to appear to independent third parties to be reasonable. It should not exceed the level that recipients would normally be prepared to pay for themselves. 17. Use of Consultants Healthcare professionals can be used as consultants and advisors, whether in groups or individually, for: - Services (e.g. chairing or speaking at meetings, being involved in medical/scientific studies or in clinical trials) - Training - Participating in advisory board meetings - Participating in market research where such participation involves remuneration and/or travel With the exception of one-off phone interviews or mail/ /internet questionnaires, the arrangements that cover these genuine consultancy or other services must fulfil all of the following criteria: 28 (i) (ii) (iii) (iv) A legitimate need must be clearly identified before the request for such services, and the arrangements with the prospective consultants, are made; A written contract or agreement, including details regarding the nature of the services to be provided and the basis for payment of those services, must be signed in advance of the commencement of the services; Criteria directly related to the identified need must drive the selection and evaluation of consultants; No greater number of healthcare professionals can be retained than is reasonably necessary to fulfil the identified need;

31 Code of Practice for the Pharmaceutical Industry (v) (vi) (vii) Records concerning the services provided by consultants must be maintained by the contracting company; The hiring of the healthcare professional to provide the relevant services must not be an inducement to prescribe, purchase, supply or sell a particular medicinal product; The compensation for the services must be reasonable and reflect the fair market value of the services provided. In this regard, token consultancy arrangements must not be used to justify compensating healthcare professionals. Consultants who have entered contractual arrangements with companies or are employed on a part-time basis while still practising their profession, should be strongly encouraged to declare their arrangements with the company, whenever they write or speak in public about a matter that is the subject of the agreement or any other issue relating to that company. Additionally, from 2016 onwards companies will be required to make public details of all Transfers of Value that occur from January 2015 (see Appendix V of this Code for full details). If a healthcare professional attends an event (an international event or otherwise) in a consultant or advisory capacity the provisions of Clause 16 covering hospitality shall apply. 18. Market Research, Post Marketing Surveillance & Related Activities 18.1 Methods used for market research must never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry. The following provisions set out in this clause apply whether the research is carried out directly by the company or by an organisation acting on its behalf Access to respondents must not be gained by subterfuge. Any incentives given must be kept to a minimum and be commensurate with the work involved. 29

32 18.3 Questions intended to solicit disparaging references to competing products or companies must be avoided Market research must not be used as a form of disguised sales promotion Post-marketing surveillance studies, pharmacoeconomic studies, non-interventional trials, clinical audit programmes and the like (including those that are retrospective in nature) commissioned, undertaken or provided by companies must never be promotional in nature and must be conducted primarily with a scientific or educational purpose. This clause does not preclude the use of the data generated from such studies to support claims in promotion. 19. Non-Interventional Studies A non-interventional study is defined as: (i) (ii) (iii) (iv) A study of one or more medicinal products which have a marketing authorisation where the products are prescribed in the usual manner in accordance with the terms of that authorisation and where; The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and where; The prescription of the medicine is clearly separated from the decision to include the patient in the study and where; No diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of the particular therapeutic strategy in question and where epidemiological methods shall be used for the analysis of data arising from the study. 30

33 Code of Practice for the Pharmaceutical Industry 19.2 Non-interventional studies that are prospective in nature and that involve the collection of patient data specifically for the study from or on behalf of individual, or groups of, healthcare professionals must comply with all of the following criteria: (i) (ii) (iii) (iv) (v) (vi) (vii) The study must be conducted with a scientific purpose; There must be a written study plan; The healthcare professionals and/or the site at which the study will take place, on the one hand, and the company sponsoring the study, on the other hand, must sign written contracts which specify the nature of the services to be provided and the basis for payment of those services; Any remuneration provided must be reasonable and reflect the fair market value of the work performed; If applicable, the study protocol must be submitted to the Ethics Committee for review; Laws, rules and regulations on personal data privacy (including the collection and use of personal data) must be respected; The study must not constitute an inducement to prescribe, purchase, supply or sell a particular medicinal product; (viii) The company s Scientific Service must approve the study protocol and supervise the conduct of non-interventional studies; (ix) The study results must be analysed by or on behalf of the contracting company and summaries thereof must be made available within a reasonable period of time to the company s Scientific Service. This Scientific Service shall maintain records of such reports for a reasonable period 31

34 of time. The company should send the summary report to all healthcare professionals that participated in the study and should make the summary report available to industry self-regulatory bodies and/or committees that are in charge of supervising or enforcing applicable Codes upon their request. If the study shows results that are important for the assessment of benefit-risk, the summary report should be immediately forwarded to the relevant competent authority; (x) Medical sales representatives may only be involved in an administrative capacity and such involvement must be under the sole supervision of the company s Scientific Service that will also ensure that the representatives are adequately trained. Such involvement must not be linked to the promotion of any medicinal product. To the extent applicable, companies are encouraged to comply with the above requirements for all other types of studies, including epidemiological studies and registries and other studies that are retrospective in nature. 20. Relations with the General Public & Lay Communication Media 20.1 Subject to the provisions of the Medicinal Products (Control of Advertising) Regulations 2007 (S.I. 541 of 2007), medicines may not be advertised or promoted to the general public if they are prescription-only medicines. This prohibition includes nonprescription medicines which by virtue of any applicable regulatory requirement, may not be advertised to the public Requests from individual members of the public for information or advice on personal medical matters must always be refused and the enquirer recommended to consult their own healthcare professional. This does not however obviate the regulatory obligation of the company to collect appropriate and comprehensive information from patients (with their consent) to